Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04217265

Enrollment

200

Registered

2020-01-03

Start date

2020-01-05

Completion date

2020-04-10

Last updated

2020-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Missed Abortion

Brief summary

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.

Detailed description

According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week letrozole administration with misoprostol raises the rate of complete abortion

Interventions

DRUGLetrozole then misoprostol

total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion

DRUGplacebo then misoprostol

placebo tablets for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Gestational age less than 64 days gestation (\<9 wks). * Hemoglobin \>10 g/dL. * BMI between 18.5 kg/m2 and 25 kg/m2. * Missed abortion.

Exclusion criteria

* Molar pregnancy. * Fibroid uterus. * Uterine anomalies. * Coagulopathy. * Medical disorder that contraindicate induction of abortion (e.g. heart failure). * Previous attempts for induction of abortion in the current pregnancy. * Allergy to misoprostol or letrozole. * Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).

Design outcomes

Primary

Measure	Time frame	Description
complete abortion rate	9 hours	Incidence of complete miscarriage
time from induction to abortion	9 hours	induction to abortion time interval

Secondary

Measure	Time frame	Description
Need for surgical evacuation of the products of conception	9 hours	how many women will undergo dilatation and curettage after failed medical induction of abortion

Contacts

Primary ContactAHMED SAMY

ahmedsamy8233@gmail.com+201100681167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026